Cassandra Ambuehl
Senior R&D Engineering Technician
Alton,IL
Even if you are on the right track, you’ll get run over if you just sit there.
Will Rodgers
Summary
An ever curious and driven technical problem solver that will fix problems and tackle any task at hand. I have 10 years of experience in the pharmaceutical and medical device industry utilizing scientific and engineering skills to improve and excel at any challenge. I am always eager to learn and hone any skill, new or old.
Overview
11
11
years of professional experience
Timeline
Senior R&D Engineering Technician - Compression - Cardinal Health
01.2022 - Current
R&D Engineering Technician II - Enteral Feeding & Thermometry - Cardinal Health
08.2018 - 01.2022
Environmental Monitoring Technician - Patheon Biologics
10.2017 - 08.2018
Buffers & Media Laboratory Technician - Patheon Biologics
08.2015 - 10.2017
Southeast Missouri State University - Bachelor of Science, Environmental Science: Biology
Work History
Senior R&D Engineering Technician - Compression
Cardinal Health
Hazelwood, MO
01.2022 - Current
- Facilitate testing and research for compression devices, sleeves and stockings to ensure product functionality and proactively resolve any issues within our product lines
- Utilize DataMasters, temperature/sound chambers, Instron tensile testing, manometers, OGP/Keyence microscopes, syringe pumps, leak testers, RF/ultrasonic welding, Magna-Mike, calipers and other scientific tools to execute studies/testing
- Document data and R&D studies via laboratory notebooks and maintain Good Documentation Practices (GDP) and adherence to government regulations for medical devices
- Write protocols for compression products and studies performed, confirming that all policies adhered to quality control/assurance standards and other best practices
- Train personnel to perform enteral feeding, thermometry and compression testing on a wide variety of instruments/machines within R&D Engineering
- Organize physical and digital Design History Files (DHFs) and legacy file storage in compression DHF library
- Supported Kendall SCD 700 tubing replacement on-site in Atlanta, GA; ensuring 1,000+ pumps reached thousands of customers after weeks of issue remediation
- Supported Kendall SCD SmartFlow software updates on-site in Hackensack, NJ; updated 500+ pumps with new software and servicing two hospital sites
- Supported Kendall SCD SmartFlow Implementation on-site in San Diego, CA; provided support and training for nurse staffing and customer support sales for new product launch across two hospital sites
R&D Engineering Technician II - Enteral Feeding & Thermometry
Cardinal Health
Hazelwood, MO
08.2018 - 01.2022
- Performed initial stability testing and other long form testing for Kangaroo OMNI Enteral Feeding pumps
- Tested Kangaroo Feeding Tube with IRIS Technology in long term studies involving the use of gastrointestinal fluid
- Tested legacy and in-development enteral feeding, thermometry and GI products by performing all product testing, requirements gathering and data analysis to provide product support
- Performed studies and research utilizing multimeters, flow rate devices, water baths, MTS tensile testing machines, testing/sound chambers, oscilloscopes and other scientific instruments
- Documented test results and other relevant data within laboratory notebooks to ensure GDP and government regulation adherence
- Supported a major reprogramming for Kangaroo Connect enteral feeding pumps on-site in Atlanta, GA; ensured 500+ pumps reached hundreds of customers after upgrades and issue remediation
Environmental Monitoring Technician
Patheon Biologics
Berkeley, MO
10.2017 - 08.2018
- Oversaw all pharmaceutical areas at the site to determine and resolve the presence of adverse bacteria/mold in cGMP manufacturing areas (both environmental and water)
- Developed dozens of barcodes for daily sampling to design water and agar monitoring worklists while maintaining accuracy and security of test tube samples
- Maintained cGMP compliance with Environmental Monitoring SOPs, clean room procedures, air monitoring equipment guidelines and contact plate/swabbing techniques
- Performed timely data analysis and entry within the MIMS database concerning mold and bacteria growth across agar rodac and settling plates
- Dressed in proper clean room attire appropriate for ISO5, ISO7 and ISO8 areas
- Cleaned and sanitized all monitoring and lab equipment via the autoclave
Buffers & Media Laboratory Technician
Patheon Biologics
Berkeley, MO
08.2015 - 10.2017
- Created dozens of buffers and media formulations daily and promoted quality control and assurance for all workers and products involved in an active cGMP production environment
- Weighed chemicals and performed quality testing to ensure quality buffers and media were properly formulated
- Facilitated scientific instrument and equipment calibration on pH and conductivity meters, turbidity meters, NOVA, and osmolality while complying with all safety precautions, SOPs and cGMP
- Trained personnel concerning cGMP manufacturing standards and policies, confirming that all personnel adhered to each policy in addition to promoting a highly organized 5S environment in a clean room
- Dressed in proper clean room attire appropriate for ISO5, ISO7 and ISO8 areas
- Performed technical records management via upper-level SAP access as well as material consumption batch report generation
- Created shift notes at the conclusion of each work day and cGMP document evaluation/review
Education
Bachelor of Science - Environmental Science: Biology
05-2015
- Magna Cum Laude
- GPA: 3.81
Skills
- Scientific Method & Test Methodology, Data Management & Analysis, Personnel Oversight & Training, Technical Writing, Chemistry, Biology, Engineering, Regulatory Compliance, Protocol & Procedure Development, Research & Development, Laboratory Experience, Quality Control & Assurance, Information Security, Product & Project Management, Clinical Applications, Customer Support Sales, cGMP Documentation and Manufacturing, Equipment Operation & Calibration, Stability Studies, Environmental Monitoring, Pharmaceutical Buffers and Media Manufacturing, Vehicle Manufacturing, Medical Devices in Compression, Enteral Feeding and Thermometry
- Chemical Formulations, Test Fixture Building, Agile, Polarion, myLearning, DataMaster, Autoclave, Aseptic and Clean Room Techniques, Instron and MTS Tensile Testing, ISO5, ISO7, ISO8, pH Meters, Conductivity Meters, NOVA, LabVIEW programming, OGP and Keyence Microscopes, Osmolality Meters, Turbidity Meters, Leak Testing, Flowmeters, Oscilloscopes, Manometers, Multimeters, Magna-Mike, RF/Ultrasonic Welding, Hipot, Microsoft Suite, Google Suite, Six Sigma, 5S, SAP Concur, cGMP, GDP, SOP, DHF, Workday
Additional Experience
- Quality Engineering Intern | North American Lighting, Inc.
- Secretary to the Environmental Science Department | Southeast Missouri State University
- Environmental Science Intern | Inter-Rail Systems, Inc.
- Continuous Improvement Intern | North American Lighting, Inc.
Work Availability
monday
tuesday
wednesday
thursday
friday
saturday
sunday
morning
afternoon
evening
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